Intravenous catheterization is typically used when frequent or continuous injections of medications or fluids for nutritional support are provided to a patient. When a long treatment period is required (e.g., longer then 3 days) a long (10 cm or longer) and soft catheter is usually used, which allows maintaining it in the patient's vein up to several months. In this procedure a single puncture of a blood vessel is made for inserting and advancing the catheter towards a selected location in a vessel wherein it is left for periodic use. In this way repetitive piercing of patient's vessels is avoided. Intravenous catheter insertion apparatuses are designed to allow inserting the catheter while preserving a sterile environment and preventing the passage of blood out via the catheter insertion apparatus.
The insertion of many intravenous catheters is carried out by placing an introducer catheter comprising an introducer needle for making the puncture (over-the-needle). After the introducer catheter is placed in the target vessel the introducer needle is withdrawn therefrom and the catheter tube may be then inserted therethrough into the selected vascular location.
Splittable catheter introducers, such as the Peel-Away® introducer, typically consist of a splittable needle-sheath having two opposing splitting tabs attached to its proximal end (i.e., trailing end) via respective shanks. The insertion of such splittable introducers into the vessel is accomplished in much the same way as the over-the-needle procedure i.e., first the blood vessel is punctured by the introducer needle contained within the needle sheath and thereafter the introducer unit is advanced into the vessel, the introducer needle is then removed, and the catheter tube is inserted into the selected vascular location. After the catheter tube is placed in the vessel the needle-sheath is removed, by retracting it from the patient's vessel and peeling it off the catheter by grasping the splitting tabs and pulling them outwardly in opposite directions, thereby tearing the sheath apart along its longitudinal length.
An intravenous catheter assembly comprising a sterile catheter insertion apparatus comprised of an integral sterile sheath containing the catheter tube therein is described in WO 03/084428. Various catheter insertion apparatuses are also described in co-pending Israeli patent application No. 166863 filed on Feb. 14, 2005, the disclosure of which is incorporated herein by reference, wherein the catheter tube contained in a sterile sleeve is inserted into the patient's vessel by utilizing catheter advancing means. However, the above mentioned catheter insertion apparatuses are designed for insertion via the conventional over-the-needle technique wherein the catheter introducer remains in the punctured vessel during the entire procedure.
JP 198479178 (Okada Yousuke) describes insertion of a catheter via a peelable sheath introduced through the nose of a patient into the stomach. A “U”-like shaped fixing device is used for retaining the catheter by a central aperture that is accessed via a slit provided in one arm, while the sheath is peeled and withdrawn outwardly via a central aperture provided in the other arm of the fixing device. The aperture of said other arm may be accessed via a slit provided therein, said aperture serves for preventing peeling of the distal section of the sheath.
EP 0,228,826 (Okada Yosuke) describes a catheter fixing device comprising an aperture, a bridge having a large hole through which the catheter may be advanced, a small hole suitable for gripping the catheter, and a slot connecting the aperture and holes through which the catheter may be moved to one of the holes. A splittable catheter sheath passes through the aperture and its proximal end is split to emerge through opposite portals of the bridge.
U.S. Pat. No. 6,558,354 (Howell Glade H.) describes an adapter that allows a needle introducer assembly having a male luer portion at its distal end to be used with a (peelable) catheter introducer that does not include a corresponding female luer portion.
U.S. Pat. No. 5,250,033 (Evans Michael A. et al) describes a peel-away introducer sheath having a pair of handle tabs and a sealing valve (or other transitional element such as a connector) detachably secured to its proximal end via a detachable threaded connector. After insertion of the catheter the introducer is withdrawn and pulled apart by pulling the tabs leaving the sealing valve over the catheter.
U.S. Pat. No. 6,585,703 (Kassel Michael) describes an introducer catheter including a tube and a proximal connector (male luer) that can be divided into two halves. The connector is used for connecting a needle guard assembly to the introducer. After insertion of the introducer the needle is retracted into the needle guard which is then removed to allow insertion of the catheter via the inserter.
In U.S. Pat. No. 4,412,832 (Kling John E. et al.) an introducer catheter assembly is described which includes a catheter tube scored along its length. The proximal end of the catheter tube is split into proximal splitting tabs located behind the location of a slidable sleeve which is telescopically mounted on the catheter tube. The slidable sleeve serves to reinforce the catheter tube and prevent split of the distal section of the catheter. After positioning an infusion catheter via the introducer lumen, the proximal end of the catheter tube can be peeled apart by pulling the proximal tabs. The introducer catheter tube is split apart as the slidable sleeve is moved toward the distal end of the introducer catheter tube until the entire catheter tube is removed.
U.S. Pat. No. 4,411,654 (Boarini Edward J.) describes an introducer catheter assembly comprising an introducer catheter tube having rupture lines along its length, and a slidable suture sleeve telescopically disposed over the introducer catheter tube. The introducer catheter is secured to a needle at a hub section by a ring. Slidable suture sleeve is originally positioned near the proximal end of catheter tube where the tube splits, such that it prevents split of distal catheter sections. After insertion of an infusion catheter the proximal splits of the tube catheter are grasped and pulled apart, thereby withdrawing the catheter tube from the patient's body and rupturing the tube along the rupture lines and eventually removing it.
The methods described above have not yet provided satisfactory solutions for interfacing between catheter appliances and splittable introducers, securing said splittable introducers, and allowing splitting their needle sheath while they are present in the body of the treated subject.
It is therefore an object of the present invention to provide means and methods for inserting a catheter tube into a selected location utilizing a splittable introducer and maintaining a sterile environment.
It is a further object of the present invention to provide means for securing and/or interfacing a splittable introducer or dilator.
It is another object of the present invention to provide an adapter for a splittable introducer capable of providing a sealed connection with auxiliary appliances such as catheter insertion apparatuses, and for facilitating the retraction and peeling of the needle sheath.
It is yet another object of the present invention to provide securing devices for preventing separation of the splittable introducer or dilator in the blood vessel, and for increasing the safety of the procedure.
An additional object of the present invention is to provide an adapter for a splittable introducer that facilitates the insertion of the catheter into the introducer.
It is still a further object of the present invention to provide an adapter for a splittable introducer and a method of using the same, which substantially minimizes movements of the catheter device in and out of the body of the treated subject during removal of the splittable introducer.
Other objects and advantages of the invention will become apparent as the description proceeds.